Randomized Clinical Trial Comparing Coronary Bypass Grafting With or Without Cardiopulmonary Bypass
Primary Purpose
Ischemic Heart Disease
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Coronary bypass surgery without cardiopulmonary bypass
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Heart Disease
Eligibility Criteria
Inclusion Criteria: Any patient suitable for CABG surgery Exclusion Criteria: Emergency, concomitant procedure, low ejection fraction (<20%)
Sites / Locations
- Queen Elizabeth II Health Sciences Center
Outcomes
Primary Outcome Measures
Length of hospitalization
Blood product utilization
Post operative atrial fibrillation
Secondary Outcome Measures
Myocardial infarction
Mortality
Full Information
NCT ID
NCT00216957
First Posted
September 19, 2005
Last Updated
September 19, 2005
Sponsor
Maritime Heart Centre
1. Study Identification
Unique Protocol Identification Number
NCT00216957
Brief Title
Randomized Clinical Trial Comparing Coronary Bypass Grafting With or Without Cardiopulmonary Bypass
Official Title
Randomized Clinical Trial Comparing Coronary Bypass Grafting With or Without Cardiopulmonary Bypass
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
October 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Maritime Heart Centre
4. Oversight
5. Study Description
Brief Summary
Coronary artery bypass grafting (CABG) is a well established treatment modality for patients with coronary artery disease. For 30 years now CABG operations have been performed with the help of the heart lung machine (Cardiopulmonary bypass). However, the heart lung machine is believed to be responsible for many of the side effects and complications seen in patients following CABG surgery. The organs most commonly affected are the brain, blood constituents, lungs and kidneys.
In the last few years, stabilising devices have been developed that allow CABG operations to be performed safely without the use of the heart lung machine. Our hypothesis was that CABG done without the heart lung machine may be better tolerated by patients resulting in lower morbidity, increased functional outcome and shorter hospital length of stay.
Enrolment into the trial was from 1998 to 2003 and included 300 patients. The last patient was enrolled in June of 2003. The initial results from the study suggest that excellent results can be obtained with both techniques and contrary to others no advantages could be demonstrated in in-hospital outcomes of patients performed without cardiopulmonary bypass (Legare et al. Circulation 2005).
Detailed Description
We are now in follow-up to evaluate the medium term and long term outcomes of all 300 patients originally enrolled in above mentioned randomized clinical trial. The follow-up of patients is approved by the Capital Health Research Ethics Board (CDHA-RS/2004-295).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Coronary bypass surgery without cardiopulmonary bypass
Primary Outcome Measure Information:
Title
Length of hospitalization
Title
Blood product utilization
Title
Post operative atrial fibrillation
Secondary Outcome Measure Information:
Title
Myocardial infarction
Title
Mortality
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any patient suitable for CABG surgery
Exclusion Criteria:
Emergency, concomitant procedure, low ejection fraction (<20%)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Francois Legare, MD
Organizational Affiliation
Dalhousie University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth II Health Sciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Randomized Clinical Trial Comparing Coronary Bypass Grafting With or Without Cardiopulmonary Bypass
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